Home / 510(k) Clearances / K101329

510(k) K101329

SYNERGY CT PICC by Health Line International Corporation — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2010
Date Received
May 12, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Health Line International Corporation

  • K222170 — Power Acute Triple Lumen Hemodialysis Catheter (January 13, 2023)
  • K200426 — Acute Dual Lumen Hemodialysis Catheter (December 24, 2020)
  • K200263 — Health Line CT Midline Catheter (March 12, 2020)
  • K192533 — Health Line CT CVC (December 10, 2019)
  • K160448 — ARTLINE (July 12, 2016)
  • K140270 — NEXUS MIDLINE CT CATHETER (August 20, 2014)
  • K130851 — CASCADE HEMODIALYSIS/APHERESIS CATHETER (January 9, 2014)
  • K130034 — UNI-PICC (March 8, 2013)
  • K120548 — HLIC NEEDLE-LESS VALVE (May 4, 2012)
  • K060352 — HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS (May 31, 2006)

Other clearances for product code LJS

  • K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC (December 16, 2025)
  • K252792 — PM2™ System with ECGuide™ Connector (November 17, 2025)
  • K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700013 (August 1, 2025)
  • K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr Hyd (July 1, 2025)
  • K243484 — PM2+ System and SmartPICC Stylet (May 29, 2025)
  • K241587 — pilot TLS (February 26, 2025)
  • K241910 — Neonav ECG Tip Location System (January 19, 2025)
  • K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001 (January 17, 2025)
  • K240486 — PM2 System and ECGuide Connector (September 8, 2024)
  • K233149 — CATHTONG III Tapered PICC Catheter (December 1, 2023)